Statutory Instruments

The European Communities (Quality and Safety of Human Blood and Blood Components) (Amendment) Regulations 2011

These Regulations give effect to Commission Implementing Directive 2011/38/EU of 11 April 2011 amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of the shelf life. Recent scientific evidence and field practice experience has demonstrated that values higher than pH 7.4 do not affect the quality and safety of stored platelets and that a maximum pH value for platelet concentrates is thus not
necessary

The Regulations also give further effect to Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC to provide that blood establishments should encourage the voluntary unpaid donation of blood and blood components

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